NIH Clinical Research Studies

Protocol Number: 03-M-0185

Active Accrual, Protocols Recruiting New Patients

Title:
Generalized Anxiety Disorder and Social Anxiety Disorder: Their Impact on the Processing of Social Emotional Information and Instrumental Learning
Number:
03-M-0185
Summary:
The purpose of this study is to increase researchers' understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. This knowledge will be used to design interventions to help those with these illnesses.

To qualify for this study, participants must be evaluated via an initial telephone screening interview and material sent through the mail.

Participants will then be required to make three visits to NIH. During the first visit, they will be asked questions about their general mood, degree of nervousness, thinking skills, and behavior. They will undergo a thorough physical exam, including an EKG, blood work, urinalysis, and a pregnancy test for women of childbearing potential. During the second visit, participants will spend about 2.5 hours doing various tasks while sitting and looking at a computer screen. These tasks will guide them to experience specific kinds of thoughts and emotions. Researchers will attach electrodes to the participants' hands to monitor the amount of electricity conducted by the skin. The third visit will be similar to the second visit, but participants will perform the tasks while lying in a MRI scanner.

Participants will be compensated up to $400 for their involvement in this study.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Age: Participants will be males and females, 18-50 years of age.

IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be greater than 80.

Medication status: No regular use of psychotropic medication within 2 weeks of the study (or fluoxetine within 8 weeks of the study). No regular use of any benzodiazepine. We intend to identify patients whose GAD/SAD is currently untreated.

EXCLUSION CRITERIA:

Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, and pregnancy precludes participation in fMRI studies, these factors are exclusionary.

(1) Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (i.e., SCID). Any current suicidal ideation will be exclusionary.

a. Healthy comparison individuals (Group 1): All participants will be free of any current psychiatric disorder as well as lifetime history of psychosis, pervasive developmental disorder, major affective disorder, panic disorder, obsessive compulsive disorder, ADHD, anorexia.

b. Patients with GAD (Group 2): Any history of an axis I diagnosis including SAD but not including adjustment disorder, simple phobia or dysthymia is exclusionary. There must be no current mood disorder (MD) though patients with past MD, which occurred after the onset of GAD, will be admitted to the study.

c. Patients with SAD (Group 3): Any current history of an axis I diagnosis apart from GAD and mood disorder (MD) but not including adjustment disorder, simple phobia or dysthymia is exclusionary. Participants will be excluded if the patient's MD preceded their SAD. We recognize the difficulty of recruiting patients with SAD without co-morbid GAD and will therefore allow patients who are comorbid into the study in this group.

(2) History of Drug Abuse: Axis I diagnoses of substance use disorders will be exclusionary.

(3) Severe acute and chronic medical illnesses.

(4) CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as a loss of consciousness greater than 3 min).

(5) Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.

(6) Claustrophobia: Participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.

(7) Pregnancy status: Because of the potential effects of hormonal changes on brain function as well as the unknown effects of electromagnetic field on the fetus, known pregnancy is an exclusion criterion.

Special Instructions:
Currently Not Provided
Keywords:
Amygdala
Orbital Frontal Cortex
Emotion
fMRI
Neurocognitive
Generalized Anxiety Disorder
Social Phobia
Orbitofrontal Cortex
Facial Affect
Instrumental Learning
Recruitment Keyword(s):
Anxiety Disorder
Generalized Anxiety Disorder
GAD
Social Anxiety Disorder
SAD
Condition(s):
Anxiety Disorders
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Mental Health

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Adolphs R, et al., Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7.

Ambrogi Lorenzini CG, et al., Neural topography and chronology of memory consolidation: a review of functional inactivation findings. Neurobiol Learn Mem. 1999 Jan;71(1):1-18. Review.

Bechara A, et al., Different contributions of the human amygdala and ventromedial prefrontal cortex to decision-making. J Neurosci. 1999 Jul 1;19(13):5473-81.

Active Accrual, Protocols Recruiting New Patients

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